Inmediate Effect of the Visualization of Action
Primary Purpose
Neck Pain, Chronic Pain, Musculoskeletal Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
observed action and motor imaginery
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring motor imaginery, mental training
Eligibility Criteria
Inclusion Criteria:
- Nos-Specific Chronic Neck Pain lasting more than 3 months
Exclusion Criteria:
- Systemic Disease diagnosed (i.e. Lupus, Fibrolyalgia or Rheumatoid Arthritis)
- Background of fractures or surgery in the cervical region
- congenital anomalies known
- infectious processes or diagnosis of active cancer at the time of the study
Sites / Locations
- CS Entrevías
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Effective movement group
Ineffective movement group
Arm Description
Observation of a video of neck movement at 100% range of movement, and imagination of the same observed movement, feeling the realization of the movement but not developing it.
Observation of a video of neck movement at 40% range of movement, and imagination of the same observed movement, feeling the realization of the movement but not developing it.
Outcomes
Primary Outcome Measures
Change in Cervical Range of Movement
CROM goniometer
Secondary Outcome Measures
Cervical Pain Disability
Neck Disability Index
Pain Intensity
Visual Ananlogue Scale: 10cm line, were the left limit means "no pain" and the right limit means "worst imaginable pain"
Catastrophizism
Pain Catastrophizing Scale
Health Related Quality of Life
EuroQoL-5D-5L
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADs)
Full Information
NCT ID
NCT03547752
First Posted
May 1, 2018
Last Updated
June 4, 2018
Sponsor
Universidad Autonoma de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT03547752
Brief Title
Inmediate Effect of the Visualization of Action
Official Title
Inmediate Effect of the Visualization of Action
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The observation of actions and motor imagery has demonstrated the activation of certain mechanisms similar to those that occur during active movement, which could induce immediate changes in the amplitudes of movement and sensorimotor variables in observed and imagined movements. The main aim of the study was test the immediate effect of a protocol of observed actions and motor imagery on cervical range of motion and pain intensity in patients with non-specific chronic neck pain (NSCNP). Randomized double-blind clinical trial in patients with DCCI at a primary health care center in the Community of Madrid. A random distribution of study subjects was made into two groups: a) cervical motion videos were presented at full range of motion and b) the videos presented showed a range of motion limited to 40%. In both groups, visualization tasks of actions were alternated with internal kinesthetic motor imagery, in periods of 1min in 2 consecutive series and with a total of 12 minutes of intervention. Cervical range of motion was assessed with a cervical goniometer and pain intensity immediately following the intervention with an Analog Visual Scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Chronic Pain, Musculoskeletal Pain
Keywords
motor imaginery, mental training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Effective movement group
Arm Type
Active Comparator
Arm Description
Observation of a video of neck movement at 100% range of movement, and imagination of the same observed movement, feeling the realization of the movement but not developing it.
Arm Title
Ineffective movement group
Arm Type
Experimental
Arm Description
Observation of a video of neck movement at 40% range of movement, and imagination of the same observed movement, feeling the realization of the movement but not developing it.
Intervention Type
Other
Intervention Name(s)
observed action and motor imaginery
Intervention Description
Observation of a video of neck movement and imagination of the same observed movement, feeling the realization of the movement but not developing it.
Primary Outcome Measure Information:
Title
Change in Cervical Range of Movement
Description
CROM goniometer
Time Frame
at the beginning and after the intervention, until the end of the study (24 hours)
Secondary Outcome Measure Information:
Title
Cervical Pain Disability
Description
Neck Disability Index
Time Frame
at the beginning and end of the intervention, until the end of the study (24 hours)
Title
Pain Intensity
Description
Visual Ananlogue Scale: 10cm line, were the left limit means "no pain" and the right limit means "worst imaginable pain"
Time Frame
at the beginning and end of the intervention, until the end of the study (24 hours)
Title
Catastrophizism
Description
Pain Catastrophizing Scale
Time Frame
at the beginning and end of the intervention, until the end of the study (24 hours)
Title
Health Related Quality of Life
Description
EuroQoL-5D-5L
Time Frame
at the beginning and end of the intervention, until the end of the study (24 hours)
Title
Anxiety and Depression
Description
Hospital Anxiety and Depression Scale (HADs)
Time Frame
at the beginning and end of the intervention, until the end of the study (24 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Nos-Specific Chronic Neck Pain lasting more than 3 months
Exclusion Criteria:
Systemic Disease diagnosed (i.e. Lupus, Fibrolyalgia or Rheumatoid Arthritis)
Background of fractures or surgery in the cervical region
congenital anomalies known
infectious processes or diagnosis of active cancer at the time of the study
Facility Information:
Facility Name
CS Entrevías
City
Madrid
ZIP/Postal Code
28053
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23794640
Citation
van Hecke O, Torrance N, Smith BH. Chronic pain epidemiology and its clinical relevance. Br J Anaesth. 2013 Jul;111(1):13-8. doi: 10.1093/bja/aet123.
Results Reference
background
PubMed Identifier
27119020
Citation
Munoz-Garcia D, Gil-Martinez A, Lopez-Lopez A, Lopez-de-Uralde-Villanueva I, La Touche R, Fernandez-Carnero J. Chronic Neck Pain and Cervico-Craniofacial Pain Patients Express Similar Levels of Neck Pain-Related Disability, Pain Catastrophizing, and Cervical Range of Motion. Pain Res Treat. 2016;2016:7296032. doi: 10.1155/2016/7296032. Epub 2016 Mar 29.
Results Reference
background
PubMed Identifier
27352085
Citation
Niddam DM, Lee SH, Su YT, Chan RC. Brain structural changes in patients with chronic myofascial pain. Eur J Pain. 2017 Jan;21(1):148-158. doi: 10.1002/ejp.911. Epub 2016 Jun 28.
Results Reference
background
PubMed Identifier
25206618
Citation
Mao C, Wei L, Zhang Q, Liao X, Yang X, Zhang M. Differences in brain structure in patients with distinct sites of chronic pain: A voxel-based morphometric analysis. Neural Regen Res. 2013 Nov 15;8(32):2981-90. doi: 10.3969/j.issn.1673-5374.2013.32.001.
Results Reference
background
PubMed Identifier
27917103
Citation
Eaves DL, Riach M, Holmes PS, Wright DJ. Motor Imagery during Action Observation: A Brief Review of Evidence, Theory and Future Research Opportunities. Front Neurosci. 2016 Nov 21;10:514. doi: 10.3389/fnins.2016.00514. eCollection 2016.
Results Reference
background
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Inmediate Effect of the Visualization of Action
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